NOVEMBER, 2014 INCLUSION OF RCF ON REACH ANNEX XIV? … · have up to 43 years of exposure to RCF (25% of all production workers in the cohort have over 20 years of exposure) and

OVERVIEW

RCF products are indispensable in modern industrial high temperature processes due to their

unique combination of thermal and physical characteristics. Any potential human health risk

related to RCF use is limited to occupational settings and no excess of respiratory disease has

been observed in exposed workers after more than 60 years of production and use. There is no

consumer exposure. RCF has been successfully substituted where technically and economically

feasible. There are no viable substitutes for the remaining applications. The “non-use” of RCF

could lead to a wide range of undesired socio-economic implications; negative impacts are

expected in terms of environmental sustainability, competitiveness, employment, process safety

and legal compliance with plant emission regulations.

Rather than causing environmental concerns, the use of RCF products is environmentally bene-

ficial. Authorisation would fail to improve worker protection in down-stream operations as it can

be circumvented via article imports. Detailed assessments of alternatives and socio-economic

implications are essential elements of an application for authorisation and can only be done

on a case-by-case basis. This would lead to an insurmountable number of applications for

authorisation, effectively blocking ECHA´s committees for an extended period of time. Even if

authorisations could be granted following a more generic approach, the uncertainty for long-term

planning driven by short review periods (compared to the service life of the affected industrial

installations; typically > 25 years) will have a negative impact on industrial investments in the EU.

In light of the fact that exposure to RCF occurs only in industrial environments, following the

principle of regulatory effectiveness, the implementation of a sufficiently protective binding occu-

pational exposure limit value (BOELV) is seen as a much more appropriate regulatory approach.

This is fully in line with the 2020 SVHC roadmap process which, besides authorisation and

restriction, supports “other regulation” where appropriate.

The combined industry sectors using RCF products stand for more than 20 million employees and a combined turnover of more than € 1500 billion per year.

INCLUSION OF RCF ON REACH ANNEX XIV?SOCIO-ECONOMIC IMPLICATIONS

27TH NOVEMBER, 2014

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27th November, 2014

INTRODUCTION

According to REACH Article 55, the objectives of the authorisation process are twofold: to prop-

erly control risk (health and environment) while maintaining a well-functioning internal market.

This should primarily be achieved via the substitution of substances of very high concern with

safer alternatives – provided these are technically and economically suitable. In this position

paper we discuss the potential impact of the inclusion of Refractory Ceramic Fibres (Al-Si-RCF

and Zr-Al-Si-RCF) – often also referred to as Alumino-Silicate Wools (ASW) – on Annex XIV, with

a focus on potential socio-economic implications.

MANUFACTURING AND USE OF RCF

RCF belongs to the group of high temperature insulation wools (HTIW) and is produced by 3

companies at 4 manufacturing sites in Europe (France, Germany, United Kingdom). In addition to

these primary manufacturing sites there is a limited number of reprocessing sites, often operated

by the RCF manufacturers, to convert the fibres into a wide range of useful product forms. ECFIA

represents all European RCF producers and some of the larger re-processors. ECFIA member

companies also produce a range of refractory materials, including other HTIW and IFB (insulating

fire bricks and castables).

RCF products are predominantly used for the thermal insulation of industrial high temperature

process equipment. RCF products were commercialised in the 1950s and have since generally

replaced “traditional” refractory materials where technically possible. The oil crisis in the 1970s,

followed by continuously rising energy costs and growing environmental sustainability concerns,

made RCF the “material of choice” in industrial thermal process and equipment design. RCF prod-

ucts have a unique combination of properties, such as thermal and chemical stability, insulation

performance, low density, thermal shock resistance and the ability to form a wide range of rigid

and flexible articles, combined with sufficient availability at relatively low costs. This has resulted

in the technical and commercial success of the material in many innovative processes, and at

the same time makes it very difficult to find viable alternatives with the same positive effect on

equipment performance and reliability as well as energy efficiency for the downstream user.

RCF products are indispensable in modern industrial high temperature processes due to their unique combination of thermal and physical characteristics.

REACH – Article 55

The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from

substances of very high concern are properly controlled and that

these substances are progressively replaced by suitable alternative

substances or technologies where these are economically and technically viable. To this

end all manufacturers, importers and downstream users applying for authorisations shall analyse

the availability of alternatives and consider their risks, and the technical and economic

feasibility of substitution.

Examples of RCF products

INCLUSION OF RCF ON REACH ANNEX XIV? SOCIO-ECONOMIC IMPLICATIONS

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27th November, 2014

RISK PROFILE – HUMAN HEALTH AND ENVIRONMENT

While the discussion of potential risks is not the primary focus of this position paper, we here

briefly summarise the RCF risk profile:

1. Human health risk (occupational risk): The potential risk is related to inhalable fibrous

dust. Animal tests conducted in the 1980s, meanwhile scientifically challenged, resulted in

fibrosis and lung tumours after chronic inhalation of very high doses of specially prepared

fibre samples. This raised concern regarding a possible human health hazard and finally led

to the classification of RCF as a cat. 2 carcinogen under the Dangerous Substances Directive

in 1997. As a consequence, RCF and its uses are covered by a range of worker protection

regulations (e.g. the Carcinogens and Mutagens Directive and its national adoptions in EU

Member States). The risk is limited to a relatively small number of industrial professionals

actively manufacturing, handling and processing RCF products (10,000 – 20,000 workers

in the EU). A long term (> 25 years) epidemiology study involving all current and former

workers of RCF manufacturers in the USA detected no increase in fibrosis and lung tumours

above background levels. In addition, we are not aware of a single occupational health case

related to RCF exposure recorded in any occupational health register after more than 60

years of use.

2. Human risk via environmental release: No relevant release has been detected in a number

of studies and environmental measurements, e.g. RCF plant stack emissions, fence line

exposure measurements and measurements at landfill sites. The results of these studies

showed levels typically below the detection limit and caused US-EPA to conclude that RCF

causes no environmental concern; the general public is not exposed to RCF.

3. Environmental risk: RCF is an environmentally inert, inorganic material made of naturally

abundant minerals. RCF products do not cause any environmental concerns at any stage

of their life cycle. Rather than causing any environmental risk, the use of RCF products is

actually environmentally beneficial because they improve resource- and energy efficiency

and help to reduce greenhouse gas (GHG) emissions, hence supporting EU climate and

energy goals.

Any potential human health risk related to RCF use is limited to occupational settings and no incremental respiratory disease has been observed in exposed workers after more than 60 years of production and use. There is no consumer exposure. Rather than causing environmental concerns, the use of RCF products is environmentally beneficial.

Prof. Dr. Mark Utell (RCOM 2014)

From a clinical perspective, it is appropriate to note that

production workers in the University of Cincinnati cohort

have up to 43 years of exposure to RCF (25% of all production

workers in the cohort have over 20 years of exposure) and no

disease above background rates has been observed. […] the studies

demonstrate that with adequate controls, RCF poses a low risk

for development of respiratory disease. […] these results are viewed as encouraging; they

certainly neither justify listing RCF as a SVHC nor the inclusion

on the Authorisation List.

PSP Agreement between OSHA, EPA and RCFC:

Upon the conclusion of the agree-ment, RCFC and EPA generally

agreed that (1) atmospheric RCF emissions are quantitatively

small, and are of negligible concern to general public health or the environment, and (2) any

initiatives taken should focus principally towards exposure

management in the workplace.


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27th November, 2014

SUBSTITUTION – SUCCESSES AND LIMITATIONS

A legal requirement to substitute RCF with “less hazardous” alternatives based on the Occupational

Safety and Health Framework Directive has resulted from the 1997 carcinogen classification. The

High Temperature Insulation Wool industry started developing alternative materials well before

this date; less respirable polycrystalline wools (PCW) were commercialised in the 1970s and less

bio-persistent alkaline earth silicate wools (AES) were developed in the late 1980s. These prod-

ucts have proven to be technically and economically viable substitutes in a range of applications.

The use of RCF products in passive fire protection, catalytic converters, diesel particulate filters

and domestic appliances, as well as in several industrial processes, was significantly reduced as a

consequence of these developments.

The remaining industrial uses are more technically demanding and cannot be substituted in an

economical fashion by these HTIW alternatives. Replacing RCF products with “traditional” refrac-

tories is often impossible in modern installations (e.g. because of weight and space constraints)

and would lead to a significant step backwards in modern thermal process technology.

RCF has been successfully substituted where technically and economically feasible. There are no viable substitutes for the remaining applications.

SOCIO-ECONOMIC IMPLICATIONS OF A “NON-USE” SCENARIO

The addition of RCF to REACH Annex XIV would have huge implications for European manufac-

turers and user industries. As imported articles containing RCF are not covered, the authorisation

procedure would lead to a highly uncompetitive situation for European manufacturers of RCF. In

addition, the relatively short review periods (shorter than the pay-back time of e.g. an industrial

furnace) would lead to significant uncertainty for the downstream user. This would impact the

possible use of RCF, and in practice lead to non-use situations, even when a REACH authorisation

would be granted.

EuP Directive, Final Report … 2014

“Alumino-silicate RCF products, better described as aluminosilicate wools, are one of the

most energy efficient insulation materials available with, in many applications, no alternatives that

have the same performance.”

Air Liquide, company, France (RCOM 2014)

“We have not yet identified a substitute with similar level

of proven compliance with the safety and reliability standards

applied to our use of RCF.”

European Aluminium Association, Belgium (RCOM 2014)

“No valid alternative has been found for temperatures above 900°C.”

Ivoclar Vivadent AG, company, Liechtenstein (RCOM 2014)

“To date, however, no alternative material, which entirely meets our technical and economical

requirements, has been identified.”

Carbolite Ltd., company, UK (RCOM 2014)

“We have been evaluating the alternatives as they have become

available on the market place (for many years). We can state that

they are not direct alternatives.”

ThyssenKrupp Steel Europe AG, company, Germany (RCOM 2014)

“A substitution of Aluminosilicate Refractory Ceramic Fibres (AL-RCF)

has been done for application where possible, but substitution is not possible for all applications.”


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27th November, 2014

The non-use of RCF products in industrial high temperature processes would cause a wide range of

socio-economic consequences that cannot be generalised, i.e. they are depending on the specific

application parameters of the thermal process in question. One or several of the implications

below could result from a non-use scenario:

1. Environmental impact: Even in cases where it could be technically possible to replace RCF

products with traditional dense or light weight refractory bricks or concretes, the resulting

environmental impact would be significant. The difference in thermal mass (up to 30 fold)

not only leads to increased GHG emissions but would also increase resource consumption

(i.e. minerals needed to produce refractories) and emissions related to transportation. After

a certain time lag it would cause a drastic increase in waste streams (landfill of refractories

after their service life). The overall carbon footprint would rise dramatically.

2. Impact on global competitiveness: The use of sub-optimal materials would, in almost all

cases, result in increased energy consumption and/or reduced service life and associated

cost of down time and repairs (e.g. AES wools in unsuitable thermal/chemical conditions,

hard refractories under the influence of cycling temperatures). The associated increase

in “cost per unit” would create a competitive disadvantage for an EU based company or

industry sector on the global market – with undesired long-term consequences for the

European industrial GDP and employment.

3. Impact on innovation: Some modern materials (e.g. high performance steel alloys) and the

resulting products require a specific heat treatment, involving steep and well controlled

heating and cooling cycles which require the use of RCF. Insulation materials with a higher

mass cannot be used to run such processes because of their thermal inertia (they take a

longer time to heat up and cool down). As a consequence these innovative processes, along

with the required know-how, would be forced outside the EU.

4. Impact on safety: Not all potential alternatives are a priori safer. In practice, all refractory

materials can release dusts (e.g. persistent granular dust) at certain stages of their life cycle

and typically require the same risk management measures as RCF dust. RCF products often

offer an immediate plant safety advantage, e.g. due to their flexible nature. Without this

flexibility, furnace doors cannot be properly sealed under high temperatures, potentially

leading to the release of hazardous fumes into the factory environment.

5. Impact on legal compliance: The European user industry needs to comply with a number of

environmental standards such as the IED (Industrial Emissions Directive) and the related

BAT conclusions. The non-use of RCF products could result in non-compliance with these

legal requirements.

The “non-use” of RCF could lead to a wide range of undesired socio-economic implications. Negative impacts are expected in terms of environmental sustainability, competitiveness, employment, process safety and legal compliance.

Carbolite Ltd., company, UK (RCOM 2014)

“This recommendation would have a major impact on our

business. We manufacture in the UK and approximately one third of the products we make are exported outside the European Union. If we

were no longer able to use these RCF materials it would put us

at a serious disadvantage in the market place outside the EU.”

EUROFER, association, Belgium (RCOM 2014)

“Therefore, prohibiting the further use of these materials would cause a negative impact in industry affecting not only manufacturers of RCF/ASW

but also many downstream users in the supply chain, increase the

energy consumption and CO2 emissions which, as mentioned

earlier, would turn into a disad-vantage position in terms of global

competitiveness for the Steel sector.”

Glass Alliance Europe, association, Belgium

“…authorisation would lead to negative impacts on energy savings

and environmental protection and ultimately undermining the

competitiveness of the industry.”

ADS Group, association, UK

”If the EU were to prevent the use of RCF from the European market

it will negatively impact the EU Aviation industry’s ability to

contain heat, provide fire protection, reduce engine generated noise and provide high temperature electrical insulation to critical components.“

centrotherm photovoltaics AG, company, Germany

“We offer our products on a highly competetive international market,

where we already are under considerable pressure to reduce cost. Our customers expect our

systems to deliver top quality process results and high productivity at low cost of ownership. All these

key success factors are prone to suffer significantly from the

substitution or Al- RCF with the currently available alternative…”


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27th November, 2014

PRACTICAL ISSUES IN AN “AUTHORISATION SCENARIO”

Industrial thermal processes are often unique and the required equipment is custom built to fulfil

a wide range of technical and environmental requirements in a safe and reliable manner. The

insulation material is an important and integral element of the equipment since it drives process

design and performance characteristics. The selection of the best combination of refractory mate-

rials is a challenging engineering task that cannot be generalised – and this leads to a number

of major practical difficulties:

1. Process designers and furnace builders are best placed to make informed substitution assess-

ments – this is already common practice and a legal requirement. Rather than expending

their resources in the authorisation process they could, instead, easily import RCF articles

from outside the EU. This would have a major impact on the European HTIW manufacturing

industry while not improving worker protection in downstream operations (installation,

maintenance, removal). The import dependency will also hamper the competitiveness of the

European downstream industry.

2. To fully satisfy the “analysis of alternatives” requirement, every industrial thermal process

would have to obtain an individual authorisation. This is not only impractical for the affected

industries; the resulting number of authorisation requests would likely overload ECHA´s

committees and result in a slowdown of the REACH process, hence limiting the ability of RAC

and SEAC to address substances with a more relevant risk profile, causing possible negative

impacts on the effectiveness and global perception of the REACH authorisation process.

3. Strictly following the REACH legal text and applicable guidance would lead to authorisation

requirements covering the “substance use” stage, i.e. the conversion of fibres into useful

articles. At this stage of the product life cycle it is, however, impossible to provide more than

a generic “analysis of alternatives” since the end use application parameters are typically

unknown to the applicant (i.e. the manufacturer of the article).

Industrial process installations often represent multi-million Euro investments, designed to

have a useful lifespan of more than 25 years. The long-term planning uncertainty driven by a

potential authorisation requirement, including review periods as short as 4 years, would cause

a strong “black list” effect, which has in some cases already led to undesired consequences.

Strict purchasing policies prohibiting the use of SVHC will force engineering decisions towards

the use of less suitable refractory materials and could trigger some or all of the socio-economic

implications described above.

Authorisation fails to improve worker protection in down-stream operations as it can be circumvented via article imports. Detailed assessments of alternatives and socio-economic implications are essential elements of an application for authorisation and can only be done on a case-by-case basis. This would lead to an insurmountable number of applications for authorisation, effectively blocking ECHA´s committees for an extended period of time. Even if authorisations could be granted following a more generic approach, the planning uncertainty driven by short review periods (compared to the service life of the affected industrial installations) would have a negative impact on industrial investments in the EU.

CECOF, association, Germany (RCOM 2014)

“ITPE (Industrial Thermal Process Equipment) is usually customized

to client preferences, based on process requirements. The life

cycle of such plants extends to at least 20 years (see ErP-ITPE).

In the preparatory study of the ErP-Directive, DG Enterprise, Lot 4 (ErP-ITPE) it was considered that

is not possible to classify ITPE by furnace type, charge bedding,

heating, envelope, production range and material to treat in the furnace. A combination of

all these parameters result in an unmanageable variety of possibil-ities and therefore a clustering of ITPE is not possible. Clustering it under REACH by inside/process

temperature in the furnace would not be sufficient because of other

main aspects which could lead to serious damages (chemical

and physical conditions).”


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27th November, 2014

SUMMARY & CONCLUSION

The inclusion of RCF on Annex XIV has a high potential of failing to achieve the objectives

outlined in REACH Article 55:

• A reduction of the human health risk is not expected since this risk during fibre production

and use (i.e. conversion into articles) is limited to an already well controlled and small

occupational cohort. Risks for workers in downstream industry are not tackled as imports of

RCF containing articles are not covered.

• There is no environmental risk associated with the production and use of RCF – but massive

potential environmental downsides in a non-use situation.

• The potential socio-economic implications related to the inclusion of RCF on Annex XIV are

far reaching and include safety, environmental and competitive downsides for European

society.

• There are a number of practical issues driven by the broad industrial use of RCF articles in

very specific custom designed processes – making individual authorisations impractical and

possibly driving RCF users to import articles from non-EU sources.

In summary, in the case of RCF the authorisation requirement appears to be disproportionate,

inefficient and potentially damaging to European industry and society as a whole. If there is a

remaining occupational health concern – even in light of already existing regulation and despite

the observed lack of human health effects – a more targeted regulatory approach is needed.

Following the principle of regulatory effectiveness, the implementation of a sufficiently protective binding occupa-tional exposure limit value (BOELV) is seen as a much more appropriate regulatory approach. This is fully in line with the 2020 SVHC roadmap process which besides authorisation and restriction supports “other regulation” where appropriate.

ACEA, association, Brussels, (RCOM 2014)

„Caused by lack of risk for human (worker-) health or environment a

prioritisation of not clear identi-fied or defined RCF for Annex XIV

is not purposeful and can cause in opposite to the aims of REACH negative effects for environment

and competitiveness of European Automobile Industry (Art 55).

In the case of the industrial use of RCF, REACH is a conflicting regulation with other EU-regu-

lations, programs and initiatives (EU 2020; ETS, EuP-Lot 4 etc.). Therefore this process should be set on hold and be evaluated in an overall view in favour of the

environment and economy.“

For further information on the implementation of a BOELV see our position paper on risk management options.

http://www.ecfia.eu/files/RCF-ASW-Risk_Management_Option_Assesment_final.pdf


http://www.ecfia.eu/files/RCF-ASW-Risk_Management_Option_Assesment_final.pdf

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NOVEMBER, 2014 INCLUSION OF RCF ON REACH ANNEX XIV? … · have up to 43 years of exposure to RCF (25% of all production workers in the cohort have over 20 years of exposure) and